Covid-19 Antigen Rapid Tests (25 Tests)

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also intended for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individual aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with self-collected
anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and not more than 48 hours) between tests. The INDICAID COVID-19 Antigen At-Home Test is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

The INDICAID COVID-19 Antigen At-Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

  • Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the INDICAID COVID19 Antigen At-Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
  • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
  • For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as, an individual with close contact with COVID-19 or with suspected

The INDICAID COVID-19 Antigen At-Home Test is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

  • This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older with symptoms of COVID-19 within the first 6 days of symptom onset.
  • This test is also intended for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individual aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
  • This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and not more than 48 hours) between tests.

Explanation of the Test

COVID-19 (short for “Coronavirus disease 2019”) is a disease first recognized in 2019 that is caused by type of novel coronavirus called SARS-CoV-2. Due to its rapid spread, the World Health Organization (WHO) recognized the disease as a global pandemic on March 11, 2020. Many individuals with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The virus is spread primarily from person to person through respiratory particles, even by individuals without symptoms.
The INDICAID COVID-19 Antigen At-Home Test is a rapid qualitative immunochromatographic assay for the determination of the presence of SARSCoV-2 antigens in anterior nasal swab specimens. Each INDICAID COVID-19 Antigen At-Home Test is single-use and can analyze one anterior nasal (nares)
swab sample. The total time required to perform one test is approximately 20 minutes from clinical specimen collection to result.
SARS-CoV-2-specific antibodies and a control antibody are immobilized onto a nitrocellulose membrane support as two distinct lines. The test line (T) region contains monoclonal anti-SARS-CoV-2 antibodies and the control line (C) region contains polyclonal control antibodies. Polyclonal and monoclonal anti-SARS-CoV-2 antibodies conjugated with red-colored latex microspheres are used to detect the SARS-CoV-2 antigen.

Intended Use

Vaccination is one of the most important and economic tools to protect the community from infectious diseases. There are about 60% of the population were fully vaccinated around the world, however, as the virus mutates continuously, the increasingly strong transmission and immune escape capabilities of the mutant strains have brought great challenges to the prevention and control of the epidemic. The emergence of many breakthrough infection cases represents that the “immune barrier” created by vaccination against the wild-type strain of COVID-19 may be flawed. Therefore we
  1. urgently need next-generation vaccines that still have high protective efficacy against mutant strains.
  2. As the world experiences a new wave of outbreaks due to the emergence of the Omicron variant, vaccine manufacturers have already stepped up for the development of vaccines against new variants. Earlier, Moderna and Pfizer had announced to start the research on candidate vaccines against Delta and Omicron variants. In China, the China Center for Disease Control and Prevention, Sinovac and Sinopharm Group received the Omicron variant virus isolated by HKU and began their work. In addition, CanSino Bio said they were also working on the development of a new vaccine against the Omicron variant.
  3. In order to support and regulate the development of COVID-19 vaccines, the Food and Drug Administration (FDA) issued the “Development and Licensure of Vaccines to Prevent COVID-19” to determine key indicators for monitoring the whole process of vaccine development.

Advantages:

– For wild type and VOCs (Alpha, Beta, Gamma, Delta, Omicron) detection;
– Can detect antigens and antibodies (including neutralizing antibodies, total antibodies, IgG, IgM, IgG antibody subtypes, etc.);
– Cover species of Human, Mouse and Monkey, to meet the needs of preclinical and clinical research;
– Strict quality control to ensure that the batch-to-batch difference and precision < 10%;
– High throughput, can detect 90+ samples within 2 hours;
– Low environmental requirements, simple operation.

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